It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even provide the correct instruction for use (IFU). Many companies find it difficult to manage labeling regulations and also remain compliant with it.
Labeling Regulation in the Pharma Industry
New avenues have opened up in the pharmaceutical industry with regards to labeling and companies are still gearing up to cope with these new implementations. The manufacturers who come under the regulations of the Drug Supply Chain Security Act (DSCSA) from the FDA must achieve complete traceability by serializing their product labels right from production until it reaches the patients. On the other hand, the EU has come up with the Falsified Medicines Directive (FMD) which the manufacturers there need to comply with. The companies need to be compliant with all these to reach out to the global markets.
Most Common Risks of Non-Compliance
There are multiple risks that pharma companies face once it is designated as non-compliant. Some have been elaborated below:.
Health Hazards: A wrong label can cause massive damage to the health of the user and might even lead to his or her death. Innumerous incidents of mislabeling that have been reported recently. The use of incorrect labels generally ends up in expensive lawsuits.
Product Withdrawal: If non-compliance is detected in labeling then the company has to undergo the process of product withdrawal. This turns out to be costly and requires investment of time and other prime resources. Thus delaying the marketing of new products and negatively impacts the revenue.
Fines & Charges: According to the FDA norms, violation of the labeling rules may not only result in fine but may also result in the company’s loss of license and imprisonment in the worst case. Still, some grace period is offered to the companies to prepare themselves.
Interrupted Supply Chain: Mislabeling affects the supply chain though not imminent. It is the product withdrawal resulting from it that may affect the supply chain adversely. There are chances that it might cripple a company.
Brand Value Harmed: Other than all the above-mentioned risks, the other most important risk that non-compliance poses is to brand value. There are chances that the companies brand value gets stained permanently and this would create an advantage for the competitors in removing the brand name completely out of sight.
Best Practices to Sustain Regulatory Labeling Compliance
With global regulations modifying with time, it is just not enough to sustain in this regulatory landscape. Improvement is necessary through the collaboration for ensuring an efficient supply chain; hence to achieve this, the below-
mentioned practices are necessary.
Unique & Standard Labeling: Recent labeling solutions are powerful enough to create a standardized labeling process. This has already been adopted by certain big enterprises. It allows you to exert full control over the entire labeling process so that you can review the quality, accuracy, and alignment with the regulatory norms. It will reduce your burden of keeping track of so many templates. Choosing a cloud-based solution would work out to your advantage.
Aligning with the Source for Accuracy: Labeling requires immense accuracy for it to be compliant. It is really difficult to keep track of the changes that are taking place in the regulatory data. The chances of inaccuracy are further heightened with the use of manually updated spreadsheets. So it is always better to directly link the labeling procedure to the source data. Recent labeling solution providers help in the integration process through systems like PLM (Product Lifecycle Management), MES (Manufacturing Execution Systems) and ERP (Enterprise Resource Planning).
Being Responsible: At times we tend to become highly dependent on IT to take care of the label designing process and even their changes according to updates. This makes the process and lengthy and extremely time-consuming. So, it is necessary to own the responsibility of each part to modify it according to updates. This helps in maintaining consistency and makes the approval process faster.
Streamline through Labeling Automation: Earlier it was difficult to maintain a connection among all those involved within the process of labeling, this in return confused and led to mislabeling. Nowadays, with the advent of automation that is being used by various labeling solution providers, streamlining the workflow has become easier. It further increases the traceability as design, artwork, review, and approval of the label all come under one roof.
Prepare for Audits Using Updated Status: With the changing norms, it is becoming difficult to keep track and update for the regulatory audits. To prepare your label for the sudden audits that the authority might initiate, technological solutions can be used. These tools retrieve relevant data and transform them into a custom report, further ensuring that the regulatory norms are being followed.
Centralized Data for Easy Entry to New Markets: All the companies are looking forward to entering new markets and to do so they need to comply with the country-specific regulations. So, it is advisable to take a single approach and create a centralized data which will make labeling management easier. Later on, they can adopt a labeling solution system that can support them in translating the document in several languages. Such tools generally have the capacity of modifying the data into 20 languages and above.
It is quite visible and obvious how the regulatory scenario is changing and standing at this point and depending on age-old practices is not feasible. The risks are mounting and hence modern and innovative solutions are what the enterprises are looking for. Moreover, there are many cloud-based labeling services that are coming up with such solutions that are not only enabling the manufacturers to remain compliant but also taking them nearer to approval. So, the decision is yours whether to seek such advancement or remain traditional.